药品注册申请号：021419
申请类型：NDA (新药申请)
申请人：SPECGX LLC
申请人全名：SPECGX LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 METHYLIN METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Yes Yes AA 2002/12/19 2002/12/19 Prescription
002 METHYLIN METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Yes Yes AA 2002/12/19 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/10/13 SUPPL-23（补充） Approval Labeling STANDARD
2021/07/19 SUPPL-10（补充） Approval Labeling STANDARD
2021/06/25 SUPPL-20（补充） Approval Labeling 901 REQUIRED
2017/01/04 SUPPL-14（补充） Approval Labeling 901 REQUIRED
2015/04/17 SUPPL-9（补充） Approval Labeling 901 REQUIRED
2014/09/15 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
2013/12/12 SUPPL-7（补充） Approval Labeling STANDARD
2013/06/14 SUPPL-6（补充） Approval Labeling STANDARD
2010/10/18 SUPPL-4（补充） Approval Labeling UNKNOWN
2007/06/07 SUPPL-1（补充） Approval Labeling STANDARD
2006/08/10 SUPPL-3（补充） Approval Labeling STANDARD
2002/12/19 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 7691880 2024/10/07 Y PDF格式
002 7691880 2024/10/07 Y PDF格式
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:5MG/5ML 治疗等效代码:AA
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021419 001 NDA METHYLIN METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription Yes Yes AA 2002/12/19 SPECGX LLC
091601 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2010/07/23 TRIS PHARMA INC
201466 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Discontinued No No AA 2013/11/12 ALLIED
204602 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2015/08/14 NOVEL LABS INC
207485 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2016/11/18 ABHAI LLC
210139 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2018/10/03 WES PHARMA INC
211647 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2020/03/30 ALKEM LABS LTD
210764 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2020/04/10 ANDA REPOSITORY
213567 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2020/06/04 QUAGEN
207417 001 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2021/01/29 ASCENT PHARMS INC
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:10MG/5ML 治疗等效代码:AA
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021419 002 NDA METHYLIN METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription Yes Yes AA 2002/12/19 SPECGX LLC
091601 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2010/07/23 TRIS PHARMA INC
201466 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Discontinued No No AA 2013/11/12 ALLIED
204602 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2015/08/14 NOVEL LABS INC
207485 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2016/11/18 ABHAI LLC
210139 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2018/10/03 WES PHARMA INC
211647 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2020/03/30 ALKEM LABS LTD
210764 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2020/04/10 ANDA REPOSITORY
213567 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2020/06/04 QUAGEN
207417 002 ANDA METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE SOLUTION;ORAL 10MG/5ML Prescription No No AA 2021/01/29 ASCENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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